Senior Specialist – IT Quality Audit - India
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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- The Senior Specialist of IT Audits will conduct both internal and external (vendor) audits as determined by a risk-based selection process, compliance exposures and business drivers within Merck’s Manufacturing Division (MMD). This role will drive continuous improvement by proactively identifying, scoping and auditing manufacturing computer systems that potentially affect patient safety, product quality, and data integrity.
- Conducts computer system audits of GMP systems/operations to ensure compliance with prevailing regulatory laws and company policies through the computer system life-cycle.
- Conducts remote assessments and on-site vendor audits in support of the procurement and life-cycle monitoring of computerized system software and third party IT services.
- Responsible for the audit planning, audit execution and formal reporting of all audit results to the responsible management.
- Ensure responses to each audit observation is obtained and that appropriate remediation and corrective or preventive actions are taken and tracked to closure.
- Presents the results of audits to senior site and divisional management, including practical recommendations to address identified risks; requiring strong negotiation and influence skills.
- Supports the development of the GMP computerized system internal and external audit programs inclusive of procedure creation, audit tools and training delivery.
- Supports the annual development and maintenance of a risk-based audit plan/schedule including scope definition.
- Provides GMP computerized system quality and compliance consultancy and expertise to colleagues.
- Supports the analysis of quality and compliance data in order to identify and lead targeted continuous improvement efforts to improve operational process effectiveness through timely investigations and effective CAPA.
- Monitors trends, identifies compliance issues and determines opportunities for quality improvements within customer areas.
- Requests applicable resources to support audit plans.
- Is responsible for ensuring delivery of high quality and timely audit information to appropriate levels of management.
- Ensures independent and non-biased role in working with quality and compliance functional area groups to prevent any audit conflicts of interest.
- Collaborates with quality and compliance colleagues, as appropriate, to assure adequate focus.
- Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions to effectively develop and advance audit strategies.
- Limited supervision required in day-to-day activities.
- Requires approximately 50 – 75% domestic and International travel for up to two weeks in duration.
Education Minimum Requirement:
Bachelor's degree in Science, Information Technology or equivalent IT experience related to IT Systems Development, Implementation and/or IT Operations.
Required Experience and Skills:
- 5-7 years of auditing experience in a highly regulated environment.
- Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system auditing for compliance to GMP regulations
- 2-3 years of experience in delivering validated IT solutions or an application support or vendor oversight role
- Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
Preferred Experience and Skills:
- 2-3 years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
- Good understanding of a IT technology operations
- CISA, CISP Certification and knowledge of frameworks established under COBIT and ITIL
- Six-Sigma Green Belt Certification